基于证候要素的溃疡性结肠炎辨证量表的初步研究
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摘要
溃疡性结肠炎(ulcerative colitis, UC),又称慢性非特异性溃疡性结肠炎,属非特异性炎症性肠病,病变主要限于大肠黏膜与黏膜下层。临床以腹痛腹泻、黏液脓血便、里急后重为主要表现,属于中医学的“痢疾”、“泄泻”、“腹痛”等范畴。中医药治疗溃疡性结肠炎在稳定病情、预防复发方面显示出明显的优势。但目前溃疡性结肠炎的中医辨证规范尚存在不统一的问题,一定程度上影响了中医对此病的辨证论治。因此,有必要进一步就其辨证规范的内容及应用模式进行探讨,为该病中医辨证规范的不断统一、完善提供依据。
证候要素是构成证候的最小单元,主要包括病位类(如心、大肠等)和病性类(如气虚、寒、血瘀等)两大类。证候要素具有数量少、执简驭繁的特点。因此,本研究拟从病证结合和证候要素入手,在本研究团队前期有关文献分析、临床调查及多种数据挖掘的基础上,制定专家问卷,对专家进行咨询、调查,进一步明确该病的常见证候要素及其特征,建立该病常见证候要素的判定标准,形成以证候要素为核心的辨证规范；为便于该规范在临床中的应用(尤其是临床研究),以此规范为内核,进一步编制具有疾病和四诊信息采集与证候辨识功能为一体的基于证候要素的溃疡性结肠炎辨证量表,既可规范采集西医疾病信息和量化的中医四诊信息,又可以此信息为基础,根据后台的证候要素判定标准,在对其证候要素辨识的基础上,根据不同病人的具体情况,灵活地组成各种证候(辨证结果),以体现中医临床辨证的灵活性和复杂性。
目的
1通过对中医辨证量表的现状分析,提出基于证候要素及病证结合建立中医辨证量表的研究思路。
2通过专家问卷调查,获取溃疡性结肠炎常见证候要素和对应症状及症状对证候要素的诊断贡献度,初步建立该疾病基于证候要素的中医辨证规范。
3以溃疡性结肠炎辨证规范为内核,编制具有疾病和四诊信息采集与证候辨识功能为一体的溃疡性结肠炎辨证量表,并进行初步的临床验证。
方法
1溃疡性结肠炎辨证量表的研究思路
通过对目前有关中医辨证规范和辨证量表模式和结构的分析,探讨从病证结合和证候要素入手研究溃疡性结肠炎中医辨证量表的思路。
2基于证候要素的溃疡性结肠炎辨证规范的初步建立
2.1溃疡性结肠炎常见证候要素的专家问卷调查研究
在前期文献、临床研究工作的基础上,制订专家问卷,对全国7个中心15家三级甲等医院从事消化系统疾病临床工作且具有副主任医师及以上职称的专家进行问卷调查,在分析专家对溃疡性结肠炎常见证候要素常见程度的集中程度与协调程度(均数、累计百分比、变异系数)的基础上,获取溃疡性结肠炎的常见证候要素。
2.2溃疡性结肠炎常见证候要素对应症及其诊断贡献度的专家问卷调查研究
对全国7个中心15家三级甲等医院从事消化系统疾病临床工作且具有副主任医师及以上职称的专家进行问卷调查,分析专家对该病常见证候要素对应症在其诊断中权重的均数与变异系数等,初步获取症在证候要素诊断中的贡献度。
2.3基于证候要素的溃疡性结肠炎辨证规范的初步建立
在本课题组前期文献研究、临床调查、多种数据分析结果基础上,通过对专家问卷调查的结果进行分析,明确该病的常见证候要素及其特征,建立该病常见证候要素的判定标准,经课题组深入讨论,形成以证候要素为核心的辨证规范,并提出常见证候要素的组合,为临床辨证提供参考。
3基于辨证规范的溃疡性结肠炎辨证量表的编制与临床验证
以溃疡性结肠炎辨证规范为内核编制辨证量表,使其兼具疾病和四诊信息采集与证候辨识功能。并进行了初步的临床验证,由专家应用此量表进行疾病信息与四诊信息的采集,通过比较分析专家经验辨证的结果与使用量表进行辨证的结果,验证辨证规范与量表的辨证能力。
结果
1溃疡性结肠炎中医辨证量表的研究思路
从量表的内容、功能、结构、条目的量化等多方面阐述当前中医辨证量表的研究现状,并针对存在的问题提出了本研究的研究思路,即建立基于病证结合和证候要素的辨证量表,具有疾病和四诊信息采集与证候辨识功能为一体的量表。
2基于证候要素的溃疡性结肠炎辨证规范的初步建立
2.1溃疡性结肠炎常见证候要素的专家问卷调查研究
2.1.1溃疡性结肠炎常见证候要素
运用专家问卷调查的方法提取溃疡性结肠炎的常见证候要素,共发放问卷96份,收回96份,回收率为100%。按照一般、比较常见和非常常见的累积百分比>75%及变异系数≤0.40的标准,确定的溃疡性结肠炎常见病位类和病性类证候要素分别为大肠、脾、肠络、胃、肾、肝,湿、气虚、气滞、阳虚、血瘀、实热、血虚、阴虚。
2.1.2溃疡性结肠炎常见证候要素的对应症状
根据前期研究结果与专家问卷分析结果,确定对证候要素具有辨证意义的症状共152个(症状条目196条,不同证候要素可以出现相同症状),其中病位类证候要素对应症状53个(症状条目65条),分别是“肝”9条、“心”6条、“脾”14条、“肺”5条、“肾”9条、“胃”8条、“大肠”12条、“肠络”2条；病性证候要素对应症状99个(症状条目131条),分别是“气虚”13条、“血虚”8条、“阴虚”17条、“阳虚”18条、“湿”17条、“实热(火)”18条、“实寒”6条、“气滞”11条、“气陷”2条、“血瘀”10条、“饮”11条。
2.2溃疡性结肠炎常见证候要素对应症及其诊断贡献度的专家问卷调查研究
问卷中设定每个证候要素诊断成立的阈值是10分,每个症状对诊断该证候要素的贡献度分值范围为1-10分,分析专家对该病常见证候要素对应症状在其诊断中权重的均数与变异系数,初步获取该病常见证候要素对应的症状和体征及其诊断贡献度,结果如下
8个病位类证候要素的对应症及其贡献度(按降序排列)：①肝：精神抑郁、急躁易怒、脉弦、胁肋胀满、善太息、胁肋疼痛、口苦、少腹胀满、胸闷,贡献度范围为7.49～4.18；②心：心悸、心烦、失眠、多梦、胸闷、气短,贡献度范围为6.90～5.51；③脾：便溏、腹泻、舌有齿痕、舌胖大、纳呆、大便溏结不调、面色萎黄、腹胀、腹痛、脉濡、黏液便、脉缓、脓血便、脉细,贡献度范围为7.96～5.55；④肺：易感冒、气短、恶风、自汗、胸闷,贡献度范围为6.30～5.27；⑤肾：五更泄、腰膝酸软、夜尿频多、腰膝酸痛、尺脉弱(尺脉沉细无力)、下肢怕冷、脉沉、完谷不化、耳鸣,贡献度范围为7.82～5.71；⑥胃：胃脘胀满、胃脘痞满、胃脘疼痛、嗳气、呕吐、厌食、恶心、泛酸,贡献度范围为7.53～6.15；⑦大肠：脓血便、黏液便、腹泻、大便粘滞不爽、便溏、肛门灼热、肠鸣漉漉、大便溏结不调、便秘、腹痛、腹胀、矢气增多,贡献度范围为8.40～6.70；⑧肠络：脓血便、黑便,贡献度范围为8.49～6.41。
11个病性类证候要素的对应症及其贡献度(按降序排列)：①气虚：少气懒言、神疲、乏力、自汗、舌有齿痕、面色淡白、脉弱、脉虚、舌淡白、面色萎黄、脉细、头晕、腹部隐痛,贡献度范围为7.44～5.60；②血虚：唇/甲/眼睑色淡、舌淡白、面色萎黄、面色淡白、脉细、头晕、经少、经闭,贡献度范围为7.90～5.59；③阴虚：五心烦热、苔少、脉细数、苔无、苔剥脱、盗汗、舌有裂纹、口咽干燥、入夜低热、午后低热、舌瘦薄、舌红、颧红、舌绛、便秘、腹部隐痛、头晕,贡献度范围为6.88～4.91；④阳虚：四肢不温、畏寒、五更泄、腹痛,喜温喜按、小便清长、面色(?)白、夜尿频多、完谷不化、舌胖大、脉虚、舌有齿痕、舌淡白、脉迟、苔滑、苔润、自汗、口淡不渴、舌淡紫,贡献度范围为7.54～5.57；⑤湿：黏液便、苔腻、大便粘滞不爽、口粘腻、脓血便,白多赤少、肠鸣漉漉、里急后重、脓血便,赤白并重、脉滑、舌有齿痕、舌胖大、渴不欲饮、脉濡、胃脘痞满、脉缓、嗜睡、脉细,贡献度范围为7.91～4.96；⑥实热(火)：肛门灼热、苔黄、脉数、脓血便,赤多白少、口臭、小便短黄、苔燥、口苦、脓血便,赤白并重、面色红赤、舌红、大便干结、舌绛、口渴、脉滑、发热、口干、里急后重,贡献度范围为7.13～5.69；⑦实寒：腹冷痛,拒按、脉紧、四肢不温、脓血便,白多赤少、脉迟、苔白,贡献度范围为7.51～6.14；⑧气滞：腹胀痛、腹胀、脉弦、胁肋胀满、胁肋胀痛、胃脘胀痛、胃脘胀满、精神抑郁、里急后重、急躁易怒、胸闷,贡献度范围为7.38～5.88；⑨气陷：肛门下坠、腹部下坠,贡献度范围为7.65～7.43；⑩血瘀：舌有瘀斑瘀点、舌紫暗、舌下络脉异常、脉涩、腹痛拒按、痛有定处、口唇青紫、肌肤甲错、面色晦暗、腹部有痞块、黑便,贡献度范围为7.60～5.79；n饮：为肠鸣漉漉、苔滑、脉滑、苔腻、腹泻、舌胖大、胃脘痞满、腹胀、脉沉、脉弦、脉紧,贡献度范围为7.08～4.46。
2.3基于证候要素的溃疡性结肠炎辨证规范的初步建立
本规范是以证候要素的诊断为核心,在证候要素诊断成立的情况下,依据中医传统辨证论治与本病常见的证候类型,将其灵活的组成证候形成辨证结果。设定每个证候要素诊断成立的阈值是10分,每个症状和体征对诊断该证候要素的贡献度的分值范围为1～10分,1分代表贡献度最小,10分代表贡献度最大。如果单独一个症状和体征的贡献度分值为10分,或2个以上症状和体征的贡献度分值累积大于等于10分时,则该证候要素的诊断成立。
证候要素对应症状对其诊断贡献度赋值是以众数、均数为依据,按照等差原则与扣分方法,将其转化成判定标准中症状指标的分值。
根据专家意见将病位类证候要素大肠与肠络作为一个证候要素大肠予以处理。
2.3.1病位类证候要素的判定标准
(1)大肠：脓血便10分、黏液便10分、大便黏滞不爽10分、便溏8分、肛门灼热8分、大便溏结不调8分、腹泻8分、肠鸣漉漉7分、便秘6分、腹痛6分、腹胀6分、矢气增多6分。
(2)脾：舌有齿痕9分、舌胖大9分、便溏9分、腹泻9分、大便溏结不调8分、纳呆7分、面色萎黄7分、腹胀6分、脉濡5分、腹痛5分、黏液便5分、脉缓4分、脓血便4分、脉细4分。
(3)胃：胃脘胀满10分、胃脘痞满9分、胃脘疼痛9分、嗳气6分、恶心5分、呕吐5分、泛酸5分、厌食5分。
(4)肾：五更泄10分、腰膝酸软9分、夜尿频多9分、腰膝酸痛8分、尺脉弱6分、下肢怕冷6分、脉沉5分、完谷不化5分、耳鸣4分。
(5)肝：脉弦9分、胁肋胀满8分、急躁易怒8分、精神抑郁7分、胁肋疼痛7分、善太息5分、少腹胀满5分、口苦5分、胸闷1分。
(6)肺：易感冒5分、自汗5分、恶风5分、气短5分、胸闷3分。
(7)心：心悸8分、心烦5分、失眠5分、胸闷4分、多梦4分、气短4分。
症状分值和≥10分,则该证候要素诊断成立。
2.3.2病性类证候要素的判定标准
(1)湿：苔腻10分、口粘腻9分、大便粘滞不爽8分、黏液便8分、脓血便,白多赤少7分、里急后重6分、脓血便,赤白并重6分、脉滑6分、肠鸣漉漉5分、舌有齿痕5分、舌胖大5分、脉濡4分、脉缓4分、渴不欲饮4分、胃脘痞满4分、嗜睡3分、脉细2分。
(2)气虚：少气懒言8分、神疲8分、自汗8分、舌有齿痕8分、乏力7分、脉弱6分、脉虚6分、舌淡白6分、面色淡白6分、面色萎黄6分、脉细5分、头晕4分、腹部隐痛4分
(3)气滞：胁肋胀痛8分、脉弦7分、胁肋胀满7分、腹胀痛7分、腹胀7分、胃脘胀痛6分、胃脘胀满6分、里急后重6分、精神抑郁6分急躁易怒5分、胸闷4分。
(4)阳虚：五更泄9分、四肢不温9分、畏寒9分、夜尿频多8分、腹痛,喜温喜按7分、小便清长7分、面色(?)白7分、脉虚6分、完谷不化6分、脉迟5分、舌胖大6分、舌有齿痕6分、舌淡白5分、苔滑5分、自汗4分、口淡不渴4分、苔润4分、舌淡紫4分。
(5)血瘀：舌有瘀斑瘀点10分、舌下络脉异常9分、脉涩8分、肌肤甲错8分、舌紫暗8分、腹部有痞块7分、口唇青紫7分、腹痛拒按、痛有定处6分、面色晦暗5分、黑便4分。
(6)实热(火)：肛门灼热8分、苔黄8分、脉数8分、面色红赤7分、口臭7分、苔燥7分、脓血便,赤多白少6分、小便短黄6分、口苦6分、舌红5分、舌绛5分、口渴5分、大便干结5分、脓血便,赤白并重5分、脉滑5分、发热4分、口干4分、里急后重4分。
(7)血虚：唇/甲/眼睑色淡10分、舌淡白9分、面色萎黄8分、面色淡白7分、脉细6分、头晕5分、经少5分、经闭4分。
(8)阴虚：五心烦热8分、苔无8分、苔少6分、苔剥脱6分、脉细数6分、盗汗6分、入夜低热5分、午后低热5分、舌有裂纹5分、舌瘦薄5分、口咽干燥5分、颧红4分、舌绛4分、舌红4分、便秘3分、腹部隐痛2分、头晕2分。
(9)气陷：肛门下坠10分、腹部下坠8分。
(10)实寒：腹冷痛,拒按10分、脉紧7分、四肢不温5分、脉迟5分、脓血便,白多赤少5分、苔白5分
(11)饮：肠鸣漉漉7分、苔滑6分、脉滑5分、舌胖大5分、腹泻5分、苔腻5分、胃脘痞满3分、腹胀3分、脉沉3分、脉弦2分、脉紧1分。
症状分值和≥10分,则该证候要素诊断成立。
3基于辨证规范的溃疡性结肠炎中医辨证量表的编制与临床验证
3.1基于辨证规范的溃疡性结肠炎中医辨证量表的编制
溃疡性结肠炎中医辨证量表是以辨证规范为内核,集疾病和四诊信息采集与证候要素的辨识功能为一体,在对其证候要素辨识的基础上,根据不同病人的具体情况,灵活地组成各种证候(辨证结果)。
主要分为七部分,第一部分是患者的一般资料；第二部分是病史特征；第三部分是溃疡性结肠炎的西医诊断依据,用于疾病诊断；第四部分是病例的纳入、排除标准；第五部分是中医症状与体征；第六部分是证候要素判断；第七部分是辨证结果。
3.2基于辨证规范的溃疡性结肠炎中医辩证量表的临床验证
本量表由从事消化系统疾病临床工作、且具有主任医师职称的中医专家亲自填写。将临床62例专家辨证结果与采用量表辨证结果进行比较分析,在有结果的15个证候要素中,专家意见和量表辨证一致的证候要素10个(66.7%),分别为肝、脾、胃、大肠、气虚、血虚、湿阻、实热、实寒、气陷,不一致的5个(33.3%),分别为肺、肾、阳虚、气滞、血瘀,反映出本研究所研制的溃疡性结肠炎辨证规范具有一定的诊断意义。
初步临床验证的经验辨证结果共有证候类型37种,均可以由本研究制定的辨证规范中病位类和病性类证候要素组合而构成。根据专家反馈溃疡性结肠炎中医辨证量表具有疾病和四诊信息采集与证候要素辨识的作用,但也存在需要完善修改之处。
结论
1以证候要素和病证结合的角度建立集疾病和四诊信息采集与证候辨识为一体的中医辨证量表,不仅能完整、规范的收集西医疾病与中医四诊信息,并且为准确辨证提供了实用性工具,为中医辨证量表研究提供模式范例。
2在前期工作的基础上,通过专家问卷调查,进一步明确了溃疡性结肠炎常见的证候要素及其特征,建立该病常见证候要素的判定标准,形成以证候要素为核心的辨证规范,简化了辨证的复杂性和多维性等问题。
3以辨证规范为内核,编制具有疾病和四诊信息采集与证候辨识功能为一体的基于证候要素的溃疡性结肠炎辨证量表,通过62例的初步临床验证,将专家经验辨证结果与量表辨证结果进行比较分析,初步认为本研究所编制的辨证规范与辨证量表具有一定的临床实用性与可操作性。
Ulcerative colitis (ulcerative colitis, UC), also called chronic nonspecific ulcerative colitis,belongs to the specificity inflammatory of bowel disease.It is mainly limited to the intestinal mucosa and the submucosa. Clinical manifestations are mainly abdominal pain, diarrhea, tenesmus, stools containing pus and blood.It belongs to "dysentery", " diarrhea ", "abdominal pain" in the traditional Chinese medicine. It shows obvious advantage in stabiling condition and preventing recurrence of traditional Chinese medicine for ulcerative colitis. But there is no unified standard on TCM syndrome differentiation of ulcerative colitis at present. This is negatively impacting TCM syndrome differentiation and treatment of the disease. Therefore, it is necessary to discuss the content and application models of differentiation standard further. And it will provide the basis for continuous improvements and unification of TCM syndrome differentiation of the disease.
Syndrome element is the smallest unit of a syndrome,mainly including the disease location (such as the heart, the large intestine, etc) and disease nature (such as qi, cold, blood stasis, etc.). Syndrome elements have the character of less amount, but it reflects the characteristics of numerous syndromes.
So the study proceeds with combination of disease and syndrome and syndrome element. Based on the previous literature review, clinical epidemiology investigation and data analysis,the expert questionnaire was made.Through questionnaires to experts and the analysis of concentration degree and coordination degree of expert opinions, the syndrome elements and their characteristics were further confirmed.Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core. In order to improve clinical application (especially clinical research), the differentiation scale of UC was established based on differentiation criterion, which had the functions of collecting disease information, TCM information of four methods and syndrome differentiation. It not only could regulate collection of disease information and TCM information of four methods, but also get accurate syndrome differentiation according to the patient's specific conditions with the background syndrome differentiation criterion. It embodies the flexibility and complexity of the syndrome differentiation in clinical practice.
Objective
1 Through the modern literature research,the present situation of differentiation scale of Chinese medicine was analyzed. The research ideas of establishing differentiation scale based on the syndrome elements and combination of disease and syndrome was proposed.
2 Through the expert questionnaire, the weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis are defined preliminarily. And differentiation criterion based on syndrome elements was set up.
3 With the differentiation criterion of ulcerative colitis as the core, differentiation scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was compiled. Using the scale as the tool, the preliminary clinical validation was carried out.
Methods
1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitis
Through the analysis of the present situation of patterns and structures of syndrome differentiation criterion and scale for TCM syndrome differentiation,the study discussed the scale for TCM syndrome differentiation of ulcerative colitis from the binding of illness and syndrom and TCM syndrome elements.
2 Establish differentiation criteria based on TCM syndrome elements
2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among experts
The questionnaire was made on the basis of previous document research and clinical study. Then the questionnaire to experts was carried out. The experts who have been engaged in medical career came from 15 third-grade class-A hospitals (7 cities) in China.Their professional titles were associate chief physician and above.The common traditional Chinese medicine (TCM) syndrome factors of ulcerative colitis were selected based on consent degree of the experts (mean value, full marks ratio and variation coefficient). 2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigation
The experts who answered the questionnaire were titled as associate chief physician or above level,and had practiced medicine regarding digestive system diseases for a long time. They came from 15 third-grade class-A hospitals (7cities) in China. The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)
2.3 Establish differentiation criteria based on TCM syndrome elements
On the basis of previous document research, clinical study, data analysis and questionnaire investigation, standardization of the syndrome differentiation based on TCM syndrome elements was preliminarily established. And TCM syndrome elements combination were provided for clinical application.
3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitis
The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.Then multi-center clinical verifications were carried out. The experts collectted disease information, TCM information of four methods with scale. By comparing and analysing traditional Chinese medicine dialectical results by the experience of expert and scale,the syndrome differentiation efficacy of scale was tested.
Results
1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitis
The analysis of the present situation of scale for TCM syndrome differentiation was done in content, function, structure, quantification of entries etc. The research thoughts were proposed.On the basis of the combination between disease and syndrome, TCM syndrome elements, the scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was established. It could not only provide a practical tool for clinical diagnosis and treatment, scientific research and teaching,and also provide template for further Scale for TCM syndrome differentiation.
2 Establish differentiation criteria based on TCM syndrome elements
2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among experts
2.1.1 Common syndrome factors of ulcerative colitis
96 questionnaires were gived out and took back. The callback rate was 100%. In accordance with cumulative percentage of common, more common and very common more than 75% and the coefficient variation less than 0.40, the common TCM syndrome factors of ulcerative colitis were confirmed.The syndrome factors related to disease location were large intestine,spleen, intestine collaterals,stomach, kidney, liver, and those related to the nature of disease were damp, qi deficiency, qi stagnation, yang deficiency, blood stasis, excessive heat, blood deficiency and yin deficiency.
2.1.2 Symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis
On the basis of previous research analysis,there were 152 symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis.53 symptoms and signs were in the diagnosis of corresponding disease location TCM syndrome elements of ulcerative colitis,9 items corresponding liver,6 items corresponding heart,14 items corresponding spleen,5 items corresponding lung,9 items corresponding kidney,8 items corresponding stomach,12 items corresponding large intestine,2 items corresponding bowel collaterals.99 symptoms and signs were in the diagnosis of corresponding disease nature TCM syndrome elements of ulcerative colitis,13 items corresponding qi deficiency,8 items corresponding xue deficiency,17 items corresponding yin deficiency,18 items corresponding yang deficiency,17 items corresponding dampness,18 items corresponding fire,6 items corresponding cold, 11 items corresponding qi stagnation,11 items corresponding qi sinking,10 items corresponding blood stasis,11 items corresponding fluid retention.
2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigation
The threshold of every TCM syndrome element was 10 in the questionnaire. The range of the weighting coefficient of every symptom was 1 to 10 point.The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)
The symptoms and signs corresponding to 8 TCM syndrome elements related to disease location and the range of weighting coefficient were listed as follows.①liver:" Emotional depression" etc 9 symptoms and signs (7.49～4.18).②heart:"Palpitation" etc 6 symptoms and signs (6.90～5.51).③spleen:"Loose stool" etc 14 symptoms and signs (7.96～ 5.55).④lung:"Susceptibility to colds" etc 5 symptoms and signs (6.30～5.27).⑤kidney:"Diarrhea before dawn" etc 9 symptoms and signs(7.82～5.71).⑥stomach:"Distension and fullness in the stomach" etc 8 symptoms and signs (7.53～6.15).⑦large intestine:"Stools containing pus and blood" etc 12 symptoms and signs (8.40～6.70).⑧bowel collaterals:"Stools containing pus and blood" etc 2 symptoms and signs (8.49～6.41)
The symptoms and signs corresponding to 11 TCM syndrome elements related to disease nature and the range of weighting coefficient were listed as follows.①qi deficiency:"Qi deficiency and disinclination to talk" etc 13 symptoms and signs (7.44～5.60).②xue deficiency:"Pale lips, nails and eyelids" etc 8 symptoms and signs (7.90～5.59).③yin deficiency:"Dysphoria with feverish sensation in chest, palms and soles" etc 17 symptoms and signs (6.88～4.91).④yang deficiency:"Cold limbs" etc 18 symptoms and signs (7.54｀5.57).⑤dampness:"Mucous stools" etc 17 symptoms and signs(7.91～4.96).⑥excess heat(fire):"Burning sensation in the anus" etc 18 symptoms and signs (7.13～5.69).⑦excess cold:"Cold abdominal pain, worse by pressure" etc 6 symptoms and signs (7.51～6.14).⑧qi stagnation:"Distending pain in the abdomen" etc 11 symptoms and signs (7.38～5.88).⑨qi sinking:"Tenesmus feeling of anus" etc 2 symptoms and signs (7.65～7.43).10 blood stasis: "Ecchymosis on tongue" etc10 symptoms and signs (7.60～5.79).(11)fluid retention "Borborygmus" etc 11 symptoms and signs (7.08～4.46)
2.3 Establish standardization of the syndrome differentiation of ulcerative colitis based TCM syndrome elements
This standardization is with the diagnosis of syndrome elements as the core. When diagnosis of syndrome elements was determined, syndrome elements were combined flexibly based on traditional Chinese medicine syndrome differentiation and common syndrome types of disease.
The threshold of every TCM syndrome element was 10. The range of the weighting coefficient of every symptom was 1 to 10 point.1 point standed for the least weighting coefficient while 10 point standed for the most weighting coefficient. When one symptom was 10 point,the diagnosis was made.Or two more symptoms were above 10 point, the diagnosis of the TCM syndrome element was made.
The diagnosis contribution of symptoms corresponding to syndrome elements is valued by the mode and mean. According to the principle of equal difference and point deduction, the scores of symptoms were translate into the index of criteria.
2.3.1 Differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease location
(1) Large intestine:Stools containing pus and blood(10 points); Mucous stool(10 points); Difficult defecation and sticky stools(10 points); Loose stool(8 points); Burning pain in the anus(8 points); Stool sometimes sloppy and sometimes bound(8 points); Diarrhea(8 points); Borborygmus(7 points); Constipation(6 points); Abdominal pain(6 points); Abdomen distention(6 points); Increased flatus(6 points).
(2) Spleen:Teeth-printed tongue(9 points); Plump tongue(9 points); Loose stool(9 points); Diarrhea(9 points); Stool sometimes sloppy and sometimes bound(8 points); Anorexia(7 points); Sallow complexion(7 points); Abdomen distention(6 points); Soft pulse(5 points); Abdominal pain(5 points); Mucous stools(5 points); Moderate pulse(5 points); Stools containing pus and blood(4 points); Thready pulse(4 points).
(3) Stomach:Distension and fullness in the stomach(10 points); Stuffiness and fullness in the stomach(9 points); Epigastric pain(9 points); Belching(6 points); Nausea(5 points); Vomiting(5 points); Acid regurgitation(5 points); Anorexia(5 points).
(4) Kidney:Diarrhea before dawn(10 points); Soreness and weakness of waist and knees(9 points); Frequent urination at night(9 points); Aching pain in waist and knees(8 points); Weak pulse at the chi portion(6 points); Fear cold of lower limbs(6 points); Deep pulse(5 points); Diarrhea with undigested food(5 points); Tinnitus(4 points).
(5) Liver:Stringy pulse(9 points); Distension and fullness in chest and hypochondrium(8 points); Irritability(8 points); Emotional depression(7 points); Hypochondriac pain(7 points);Deep sighing(5 points); Distension and fullness in the lateral lower abdomen(6 points); Bitter taste in the mouth(5 points);Oppression in the chest(1 points).
(6) Lung:Susceptibility to colds(5 points); Spontaneous sweating(5 points); Aversion to wind(5 points); Shortness of breath(5 points); Oppression in the chest(1 points).
(7) Heart:Palpitation(8 points); Insomnia(5 points); Vexation(5 points); Oppression in the chest(4 points); Dreaminess(4 points); Shortness of breath(4 points).
If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made.
2.3.2 differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease nature
(1) Dampness:Greasy coating(10 points); Sticky slimy sensation in the mouth(10 points); Difficult defecation and mucous stools(8 points); Mucous stools(8 points); Stools with the blood and pus; more pus and less blood(7 points); Tenesmus(6 points); Stools containing pus and blood; blood as much as pus(6 points); Slippery pulse(6 points); Borborygmus(5 points); Teeth-printed tongue(5 points); Plump tongue(5 points); Soft pulse(4 points); Moderate pulse(4 points); Thirst without a desire to drink(4 points); Stuffiness and fullness in the stomach(4 points); Analeptic(3 points); Thready pulse(2 points).
(2) Qi deficiency:Qi deficiency and disinclination to talk(8 points); Spiritlessness(8 points); Spontaneous sweating(8 points); Teeth-printed tongue(8 points); Weakness(7 points); Weak pulse(6 points); Feeble pulse(6 points); Pale tongue(6 points); Pale white complexion(6 points); Sallow complexion(6 points);Thready pulse(5 points); Dizziness(4 points); Dull pain in the abdomen(4 points).
(3) Qi stagnation:Distending pain of hypochondrium(8 points); Stringy pulse(7 points); Distension and fullness in hypochondrium(7 points); Distending pain in the abdomen(7 points);Abdominal distention(7 points); Distending pain in the stomach(6 points); Distension and fullness in stomach(6 points);Tenesmus(6 points); Emotional depression(6 points); Irritability(5 points); Oppression in the chest(4 points).
(4) Yang deficiency:Diarrhea before dawn(9 points); Cold limbs(9 points); Fear of cold(9 points); Frequent urination at night(8 points); Abdominal pain; alleviated by heat and pressure(7 points); Clear urine in large amounts(7 points); Bright pale complexion(7 points); Feeble pulse(7 points); Diarrhea with undigested food(6 points); Slow pulse(6 points); Plump tongue(6 points); Teeth-printed tongue(6 points); Pale tongue(5 points); Slippery fur(5 points); Spontaneous sweating(4 points); Bland taste in the mouth with no desire for drinking(4 points); Moist fur(4 points); Pale purple tongue(4 points).
(5) Blood stasis:Ecchymosis on tongue(10 points); Abnormal sublingual vessel(9 points); Hesitant pulse(8 points); Squamous and dry skin(8 points); Deep purple tongue(8 points); Mass in the abdomen(7 points); Cyanotic lips(7 points); Impalpable abdominal pain with fixed location(6 points); Dim complexion(5 points); Black stools(4 points).
(6) Excessive heat (fire):Burning sensation in the anus(8 points); Yellow fur(8 points); Rapid pulse(8 points); Red complexion(7 points); Halitosis(7 points); Dry fur(7 points); Stools containing pus and blood; more blood and less pus(6 points); Bitter taste in the mouth(6 points); Dark urine(5 points); Red tongue(5 points); Deep red tongue(5 points); Thirst(5 points); Dry stools(5 points); Stools containing pus and blood; blood as much as pus(5 points); Slippery pulse(5 points); Fever(4 points); Dry mouth(4 points); Tenesmus(4 points).
(7) Xue deficiency:Pale lips;nails and eyelids(10 points); Pale tongue(9 points); Sallow complexion(8 points); Pale white complexion(8 points); Thready pulse(6 points); Dizziness(5 points); Scanty menstruation(5 points); Amenorrhea (4 points).
(8) Yin deficiency:Dysphoria with feverish in the chest; palms and soles(8 points); No fur(8 points); Little fur(6 points); Eroded fur(6 points); Thready and rapid pulse(6 points); Night sweating(6 points); Mild fever in the night(5 points); Mild fever in the afternoon(6 points); Fissured tongue(5 points); Thin tongue(5 points); Dry mouth and throat(5 points); Hectic cheek(4 points); Deep red tongue(4 points); Red tongue(4 points); Constipation(3 points); Dull pain in the abdomen(2 points); Dizziness(2 points).
(9) Qi sinking:Tenesmus feeling of anus(10 points); Tenesmus feeling of abdomen(8 points).
(10) Excessive cold:Cold abdominal pain; worse by pressure(10 points); Tight pulse(7 points); Cold limbs(5 points); Slow pulse(5 points); Stools containing pus and blood; more pus and less blood(5 points); White fur(5 points).
(11) Fluid retention:Borborygmus(7 points); Slippery fur(6 points); Slippery pulse(5 points); Plump tongue(5 points); Diarrhea(5 points); Greasy fur(5 points); Stuffiness and fullness in the stomach(3 points); Distention in the abdomen(3 points); Deep pulse(3 points); Stringy pulse(2 points); Tight pulse(1 points).
If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made.
3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitis
The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.It was divided into severn parts,the first part was about general information of patients,the second part was about victim's past medical history,the third part was diagnostic criteria of ulcerative colitis,the fourth part was inclusive criteria and exclusion criteria,the fifth part was symptoms and signs,the sixth part was diagnosis of syndrome elements,the seventh part was result of syndrome differentiation.
The experts were titled as chief physician, and had practiced medicine regarding digestive system diseases for a long time. By comparing and analysing traditional Chinese medicine dialectical results of the experience of expert and scale, ten syndrome elements were consistent (66.7%).They were respectiely liver, spleen, stomach,large intestine, qi deficiency, blood deficiency, dampness, excess heat, excess cold, qi sinking. Five syndrome elements were not consistent (33.3%).They were lung, kidney, yang deficiency, qi stagnation,and blood stasis.
All the 37 syndrome types by expert experience could be formulated by the syndrome elements of syndrome differentiation standard.The information collection and syndrome differentiation efficacy of scale were tested.The scale played an important role in syndrome differentiation. But there were needs for modifications and improvements.
Conclusion
1 On the basis of binding of illness and syndrom, TCM syndrome elements, the scale with the functions of collectting disease information, TCM information of four methods and syndrome differentiation was established. It could not only collect four physical examinations information fully and objectively, and also provide a practical tool for syndrome differentiation. It reflected wholeness and flexibility of syndrome differentiation. It could provide template for further Scale for TCM syndrome differentiation.
2 Based on the previous study,the expert questionnaire was established.Through questionnaire to the experts and the analysis of questionnaire, the syndrome elements and their characteristics were further confirmed. Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core..It simplifies the complexity and the multidimensional nature of syndrome differentiation.
3 The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease and four diagnostic information and syndrome differentiation.By comparing and analysing traditional Chinese medicine dialectical results of 62 cases by the experience of expert and scale,the practical applicability and operability of the scale were showed.
证候要素是构成证候的最小单元,主要包括病位类(如心、大肠等)和病性类(如气虚、寒、血瘀等)两大类。证候要素具有数量少、执简驭繁的特点。因此,本研究拟从病证结合和证候要素入手,在本研究团队前期有关文献分析、临床调查及多种数据挖掘的基础上,制定专家问卷,对专家进行咨询、调查,进一步明确该病的常见证候要素及其特征,建立该病常见证候要素的判定标准,形成以证候要素为核心的辨证规范；为便于该规范在临床中的应用(尤其是临床研究),以此规范为内核,进一步编制具有疾病和四诊信息采集与证候辨识功能为一体的基于证候要素的溃疡性结肠炎辨证量表,既可规范采集西医疾病信息和量化的中医四诊信息,又可以此信息为基础,根据后台的证候要素判定标准,在对其证候要素辨识的基础上,根据不同病人的具体情况,灵活地组成各种证候(辨证结果),以体现中医临床辨证的灵活性和复杂性。
目的
1通过对中医辨证量表的现状分析,提出基于证候要素及病证结合建立中医辨证量表的研究思路。
2通过专家问卷调查,获取溃疡性结肠炎常见证候要素和对应症状及症状对证候要素的诊断贡献度,初步建立该疾病基于证候要素的中医辨证规范。
3以溃疡性结肠炎辨证规范为内核,编制具有疾病和四诊信息采集与证候辨识功能为一体的溃疡性结肠炎辨证量表,并进行初步的临床验证。
方法
1溃疡性结肠炎辨证量表的研究思路
通过对目前有关中医辨证规范和辨证量表模式和结构的分析,探讨从病证结合和证候要素入手研究溃疡性结肠炎中医辨证量表的思路。
2基于证候要素的溃疡性结肠炎辨证规范的初步建立
2.1溃疡性结肠炎常见证候要素的专家问卷调查研究
在前期文献、临床研究工作的基础上,制订专家问卷,对全国7个中心15家三级甲等医院从事消化系统疾病临床工作且具有副主任医师及以上职称的专家进行问卷调查,在分析专家对溃疡性结肠炎常见证候要素常见程度的集中程度与协调程度(均数、累计百分比、变异系数)的基础上,获取溃疡性结肠炎的常见证候要素。
2.2溃疡性结肠炎常见证候要素对应症及其诊断贡献度的专家问卷调查研究
对全国7个中心15家三级甲等医院从事消化系统疾病临床工作且具有副主任医师及以上职称的专家进行问卷调查,分析专家对该病常见证候要素对应症在其诊断中权重的均数与变异系数等,初步获取症在证候要素诊断中的贡献度。
2.3基于证候要素的溃疡性结肠炎辨证规范的初步建立
在本课题组前期文献研究、临床调查、多种数据分析结果基础上,通过对专家问卷调查的结果进行分析,明确该病的常见证候要素及其特征,建立该病常见证候要素的判定标准,经课题组深入讨论,形成以证候要素为核心的辨证规范,并提出常见证候要素的组合,为临床辨证提供参考。
3基于辨证规范的溃疡性结肠炎辨证量表的编制与临床验证
以溃疡性结肠炎辨证规范为内核编制辨证量表,使其兼具疾病和四诊信息采集与证候辨识功能。并进行了初步的临床验证,由专家应用此量表进行疾病信息与四诊信息的采集,通过比较分析专家经验辨证的结果与使用量表进行辨证的结果,验证辨证规范与量表的辨证能力。
结果
1溃疡性结肠炎中医辨证量表的研究思路
从量表的内容、功能、结构、条目的量化等多方面阐述当前中医辨证量表的研究现状,并针对存在的问题提出了本研究的研究思路,即建立基于病证结合和证候要素的辨证量表,具有疾病和四诊信息采集与证候辨识功能为一体的量表。
2基于证候要素的溃疡性结肠炎辨证规范的初步建立
2.1溃疡性结肠炎常见证候要素的专家问卷调查研究
2.1.1溃疡性结肠炎常见证候要素
运用专家问卷调查的方法提取溃疡性结肠炎的常见证候要素,共发放问卷96份,收回96份,回收率为100%。按照一般、比较常见和非常常见的累积百分比>75%及变异系数≤0.40的标准,确定的溃疡性结肠炎常见病位类和病性类证候要素分别为大肠、脾、肠络、胃、肾、肝,湿、气虚、气滞、阳虚、血瘀、实热、血虚、阴虚。
2.1.2溃疡性结肠炎常见证候要素的对应症状
根据前期研究结果与专家问卷分析结果,确定对证候要素具有辨证意义的症状共152个(症状条目196条,不同证候要素可以出现相同症状),其中病位类证候要素对应症状53个(症状条目65条),分别是“肝”9条、“心”6条、“脾”14条、“肺”5条、“肾”9条、“胃”8条、“大肠”12条、“肠络”2条；病性证候要素对应症状99个(症状条目131条),分别是“气虚”13条、“血虚”8条、“阴虚”17条、“阳虚”18条、“湿”17条、“实热(火)”18条、“实寒”6条、“气滞”11条、“气陷”2条、“血瘀”10条、“饮”11条。
2.2溃疡性结肠炎常见证候要素对应症及其诊断贡献度的专家问卷调查研究
问卷中设定每个证候要素诊断成立的阈值是10分,每个症状对诊断该证候要素的贡献度分值范围为1-10分,分析专家对该病常见证候要素对应症状在其诊断中权重的均数与变异系数,初步获取该病常见证候要素对应的症状和体征及其诊断贡献度,结果如下
8个病位类证候要素的对应症及其贡献度(按降序排列)：①肝：精神抑郁、急躁易怒、脉弦、胁肋胀满、善太息、胁肋疼痛、口苦、少腹胀满、胸闷,贡献度范围为7.49～4.18；②心：心悸、心烦、失眠、多梦、胸闷、气短,贡献度范围为6.90～5.51；③脾：便溏、腹泻、舌有齿痕、舌胖大、纳呆、大便溏结不调、面色萎黄、腹胀、腹痛、脉濡、黏液便、脉缓、脓血便、脉细,贡献度范围为7.96～5.55；④肺：易感冒、气短、恶风、自汗、胸闷,贡献度范围为6.30～5.27；⑤肾：五更泄、腰膝酸软、夜尿频多、腰膝酸痛、尺脉弱(尺脉沉细无力)、下肢怕冷、脉沉、完谷不化、耳鸣,贡献度范围为7.82～5.71；⑥胃：胃脘胀满、胃脘痞满、胃脘疼痛、嗳气、呕吐、厌食、恶心、泛酸,贡献度范围为7.53～6.15；⑦大肠：脓血便、黏液便、腹泻、大便粘滞不爽、便溏、肛门灼热、肠鸣漉漉、大便溏结不调、便秘、腹痛、腹胀、矢气增多,贡献度范围为8.40～6.70；⑧肠络：脓血便、黑便,贡献度范围为8.49～6.41。
11个病性类证候要素的对应症及其贡献度(按降序排列)：①气虚：少气懒言、神疲、乏力、自汗、舌有齿痕、面色淡白、脉弱、脉虚、舌淡白、面色萎黄、脉细、头晕、腹部隐痛,贡献度范围为7.44～5.60；②血虚：唇/甲/眼睑色淡、舌淡白、面色萎黄、面色淡白、脉细、头晕、经少、经闭,贡献度范围为7.90～5.59；③阴虚：五心烦热、苔少、脉细数、苔无、苔剥脱、盗汗、舌有裂纹、口咽干燥、入夜低热、午后低热、舌瘦薄、舌红、颧红、舌绛、便秘、腹部隐痛、头晕,贡献度范围为6.88～4.91；④阳虚：四肢不温、畏寒、五更泄、腹痛,喜温喜按、小便清长、面色(?)白、夜尿频多、完谷不化、舌胖大、脉虚、舌有齿痕、舌淡白、脉迟、苔滑、苔润、自汗、口淡不渴、舌淡紫,贡献度范围为7.54～5.57；⑤湿：黏液便、苔腻、大便粘滞不爽、口粘腻、脓血便,白多赤少、肠鸣漉漉、里急后重、脓血便,赤白并重、脉滑、舌有齿痕、舌胖大、渴不欲饮、脉濡、胃脘痞满、脉缓、嗜睡、脉细,贡献度范围为7.91～4.96；⑥实热(火)：肛门灼热、苔黄、脉数、脓血便,赤多白少、口臭、小便短黄、苔燥、口苦、脓血便,赤白并重、面色红赤、舌红、大便干结、舌绛、口渴、脉滑、发热、口干、里急后重,贡献度范围为7.13～5.69；⑦实寒：腹冷痛,拒按、脉紧、四肢不温、脓血便,白多赤少、脉迟、苔白,贡献度范围为7.51～6.14；⑧气滞：腹胀痛、腹胀、脉弦、胁肋胀满、胁肋胀痛、胃脘胀痛、胃脘胀满、精神抑郁、里急后重、急躁易怒、胸闷,贡献度范围为7.38～5.88；⑨气陷：肛门下坠、腹部下坠,贡献度范围为7.65～7.43；⑩血瘀：舌有瘀斑瘀点、舌紫暗、舌下络脉异常、脉涩、腹痛拒按、痛有定处、口唇青紫、肌肤甲错、面色晦暗、腹部有痞块、黑便,贡献度范围为7.60～5.79；n饮：为肠鸣漉漉、苔滑、脉滑、苔腻、腹泻、舌胖大、胃脘痞满、腹胀、脉沉、脉弦、脉紧,贡献度范围为7.08～4.46。
2.3基于证候要素的溃疡性结肠炎辨证规范的初步建立
本规范是以证候要素的诊断为核心,在证候要素诊断成立的情况下,依据中医传统辨证论治与本病常见的证候类型,将其灵活的组成证候形成辨证结果。设定每个证候要素诊断成立的阈值是10分,每个症状和体征对诊断该证候要素的贡献度的分值范围为1～10分,1分代表贡献度最小,10分代表贡献度最大。如果单独一个症状和体征的贡献度分值为10分,或2个以上症状和体征的贡献度分值累积大于等于10分时,则该证候要素的诊断成立。
证候要素对应症状对其诊断贡献度赋值是以众数、均数为依据,按照等差原则与扣分方法,将其转化成判定标准中症状指标的分值。
根据专家意见将病位类证候要素大肠与肠络作为一个证候要素大肠予以处理。
2.3.1病位类证候要素的判定标准
(1)大肠：脓血便10分、黏液便10分、大便黏滞不爽10分、便溏8分、肛门灼热8分、大便溏结不调8分、腹泻8分、肠鸣漉漉7分、便秘6分、腹痛6分、腹胀6分、矢气增多6分。
(2)脾：舌有齿痕9分、舌胖大9分、便溏9分、腹泻9分、大便溏结不调8分、纳呆7分、面色萎黄7分、腹胀6分、脉濡5分、腹痛5分、黏液便5分、脉缓4分、脓血便4分、脉细4分。
(3)胃：胃脘胀满10分、胃脘痞满9分、胃脘疼痛9分、嗳气6分、恶心5分、呕吐5分、泛酸5分、厌食5分。
(4)肾：五更泄10分、腰膝酸软9分、夜尿频多9分、腰膝酸痛8分、尺脉弱6分、下肢怕冷6分、脉沉5分、完谷不化5分、耳鸣4分。
(5)肝：脉弦9分、胁肋胀满8分、急躁易怒8分、精神抑郁7分、胁肋疼痛7分、善太息5分、少腹胀满5分、口苦5分、胸闷1分。
(6)肺：易感冒5分、自汗5分、恶风5分、气短5分、胸闷3分。
(7)心：心悸8分、心烦5分、失眠5分、胸闷4分、多梦4分、气短4分。
症状分值和≥10分,则该证候要素诊断成立。
2.3.2病性类证候要素的判定标准
(1)湿：苔腻10分、口粘腻9分、大便粘滞不爽8分、黏液便8分、脓血便,白多赤少7分、里急后重6分、脓血便,赤白并重6分、脉滑6分、肠鸣漉漉5分、舌有齿痕5分、舌胖大5分、脉濡4分、脉缓4分、渴不欲饮4分、胃脘痞满4分、嗜睡3分、脉细2分。
(2)气虚：少气懒言8分、神疲8分、自汗8分、舌有齿痕8分、乏力7分、脉弱6分、脉虚6分、舌淡白6分、面色淡白6分、面色萎黄6分、脉细5分、头晕4分、腹部隐痛4分
(3)气滞：胁肋胀痛8分、脉弦7分、胁肋胀满7分、腹胀痛7分、腹胀7分、胃脘胀痛6分、胃脘胀满6分、里急后重6分、精神抑郁6分急躁易怒5分、胸闷4分。
(4)阳虚：五更泄9分、四肢不温9分、畏寒9分、夜尿频多8分、腹痛,喜温喜按7分、小便清长7分、面色(?)白7分、脉虚6分、完谷不化6分、脉迟5分、舌胖大6分、舌有齿痕6分、舌淡白5分、苔滑5分、自汗4分、口淡不渴4分、苔润4分、舌淡紫4分。
(5)血瘀：舌有瘀斑瘀点10分、舌下络脉异常9分、脉涩8分、肌肤甲错8分、舌紫暗8分、腹部有痞块7分、口唇青紫7分、腹痛拒按、痛有定处6分、面色晦暗5分、黑便4分。
(6)实热(火)：肛门灼热8分、苔黄8分、脉数8分、面色红赤7分、口臭7分、苔燥7分、脓血便,赤多白少6分、小便短黄6分、口苦6分、舌红5分、舌绛5分、口渴5分、大便干结5分、脓血便,赤白并重5分、脉滑5分、发热4分、口干4分、里急后重4分。
(7)血虚：唇/甲/眼睑色淡10分、舌淡白9分、面色萎黄8分、面色淡白7分、脉细6分、头晕5分、经少5分、经闭4分。
(8)阴虚：五心烦热8分、苔无8分、苔少6分、苔剥脱6分、脉细数6分、盗汗6分、入夜低热5分、午后低热5分、舌有裂纹5分、舌瘦薄5分、口咽干燥5分、颧红4分、舌绛4分、舌红4分、便秘3分、腹部隐痛2分、头晕2分。
(9)气陷：肛门下坠10分、腹部下坠8分。
(10)实寒：腹冷痛,拒按10分、脉紧7分、四肢不温5分、脉迟5分、脓血便,白多赤少5分、苔白5分
(11)饮：肠鸣漉漉7分、苔滑6分、脉滑5分、舌胖大5分、腹泻5分、苔腻5分、胃脘痞满3分、腹胀3分、脉沉3分、脉弦2分、脉紧1分。
症状分值和≥10分,则该证候要素诊断成立。
3基于辨证规范的溃疡性结肠炎中医辨证量表的编制与临床验证
3.1基于辨证规范的溃疡性结肠炎中医辨证量表的编制
溃疡性结肠炎中医辨证量表是以辨证规范为内核,集疾病和四诊信息采集与证候要素的辨识功能为一体,在对其证候要素辨识的基础上,根据不同病人的具体情况,灵活地组成各种证候(辨证结果)。
主要分为七部分,第一部分是患者的一般资料；第二部分是病史特征；第三部分是溃疡性结肠炎的西医诊断依据,用于疾病诊断；第四部分是病例的纳入、排除标准；第五部分是中医症状与体征；第六部分是证候要素判断；第七部分是辨证结果。
3.2基于辨证规范的溃疡性结肠炎中医辩证量表的临床验证
本量表由从事消化系统疾病临床工作、且具有主任医师职称的中医专家亲自填写。将临床62例专家辨证结果与采用量表辨证结果进行比较分析,在有结果的15个证候要素中,专家意见和量表辨证一致的证候要素10个(66.7%),分别为肝、脾、胃、大肠、气虚、血虚、湿阻、实热、实寒、气陷,不一致的5个(33.3%),分别为肺、肾、阳虚、气滞、血瘀,反映出本研究所研制的溃疡性结肠炎辨证规范具有一定的诊断意义。
初步临床验证的经验辨证结果共有证候类型37种,均可以由本研究制定的辨证规范中病位类和病性类证候要素组合而构成。根据专家反馈溃疡性结肠炎中医辨证量表具有疾病和四诊信息采集与证候要素辨识的作用,但也存在需要完善修改之处。
结论
1以证候要素和病证结合的角度建立集疾病和四诊信息采集与证候辨识为一体的中医辨证量表,不仅能完整、规范的收集西医疾病与中医四诊信息,并且为准确辨证提供了实用性工具,为中医辨证量表研究提供模式范例。
2在前期工作的基础上,通过专家问卷调查,进一步明确了溃疡性结肠炎常见的证候要素及其特征,建立该病常见证候要素的判定标准,形成以证候要素为核心的辨证规范,简化了辨证的复杂性和多维性等问题。
3以辨证规范为内核,编制具有疾病和四诊信息采集与证候辨识功能为一体的基于证候要素的溃疡性结肠炎辨证量表,通过62例的初步临床验证,将专家经验辨证结果与量表辨证结果进行比较分析,初步认为本研究所编制的辨证规范与辨证量表具有一定的临床实用性与可操作性。
Ulcerative colitis (ulcerative colitis, UC), also called chronic nonspecific ulcerative colitis,belongs to the specificity inflammatory of bowel disease.It is mainly limited to the intestinal mucosa and the submucosa. Clinical manifestations are mainly abdominal pain, diarrhea, tenesmus, stools containing pus and blood.It belongs to "dysentery", " diarrhea ", "abdominal pain" in the traditional Chinese medicine. It shows obvious advantage in stabiling condition and preventing recurrence of traditional Chinese medicine for ulcerative colitis. But there is no unified standard on TCM syndrome differentiation of ulcerative colitis at present. This is negatively impacting TCM syndrome differentiation and treatment of the disease. Therefore, it is necessary to discuss the content and application models of differentiation standard further. And it will provide the basis for continuous improvements and unification of TCM syndrome differentiation of the disease.
Syndrome element is the smallest unit of a syndrome,mainly including the disease location (such as the heart, the large intestine, etc) and disease nature (such as qi, cold, blood stasis, etc.). Syndrome elements have the character of less amount, but it reflects the characteristics of numerous syndromes.
So the study proceeds with combination of disease and syndrome and syndrome element. Based on the previous literature review, clinical epidemiology investigation and data analysis,the expert questionnaire was made.Through questionnaires to experts and the analysis of concentration degree and coordination degree of expert opinions, the syndrome elements and their characteristics were further confirmed.Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core. In order to improve clinical application (especially clinical research), the differentiation scale of UC was established based on differentiation criterion, which had the functions of collecting disease information, TCM information of four methods and syndrome differentiation. It not only could regulate collection of disease information and TCM information of four methods, but also get accurate syndrome differentiation according to the patient's specific conditions with the background syndrome differentiation criterion. It embodies the flexibility and complexity of the syndrome differentiation in clinical practice.
Objective
1 Through the modern literature research,the present situation of differentiation scale of Chinese medicine was analyzed. The research ideas of establishing differentiation scale based on the syndrome elements and combination of disease and syndrome was proposed.
2 Through the expert questionnaire, the weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis are defined preliminarily. And differentiation criterion based on syndrome elements was set up.
3 With the differentiation criterion of ulcerative colitis as the core, differentiation scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was compiled. Using the scale as the tool, the preliminary clinical validation was carried out.
Methods
1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitis
Through the analysis of the present situation of patterns and structures of syndrome differentiation criterion and scale for TCM syndrome differentiation,the study discussed the scale for TCM syndrome differentiation of ulcerative colitis from the binding of illness and syndrom and TCM syndrome elements.
2 Establish differentiation criteria based on TCM syndrome elements
2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among experts
The questionnaire was made on the basis of previous document research and clinical study. Then the questionnaire to experts was carried out. The experts who have been engaged in medical career came from 15 third-grade class-A hospitals (7 cities) in China.Their professional titles were associate chief physician and above.The common traditional Chinese medicine (TCM) syndrome factors of ulcerative colitis were selected based on consent degree of the experts (mean value, full marks ratio and variation coefficient). 2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigation
The experts who answered the questionnaire were titled as associate chief physician or above level,and had practiced medicine regarding digestive system diseases for a long time. They came from 15 third-grade class-A hospitals (7cities) in China. The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)
2.3 Establish differentiation criteria based on TCM syndrome elements
On the basis of previous document research, clinical study, data analysis and questionnaire investigation, standardization of the syndrome differentiation based on TCM syndrome elements was preliminarily established. And TCM syndrome elements combination were provided for clinical application.
3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitis
The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.Then multi-center clinical verifications were carried out. The experts collectted disease information, TCM information of four methods with scale. By comparing and analysing traditional Chinese medicine dialectical results by the experience of expert and scale,the syndrome differentiation efficacy of scale was tested.
Results
1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitis
The analysis of the present situation of scale for TCM syndrome differentiation was done in content, function, structure, quantification of entries etc. The research thoughts were proposed.On the basis of the combination between disease and syndrome, TCM syndrome elements, the scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was established. It could not only provide a practical tool for clinical diagnosis and treatment, scientific research and teaching,and also provide template for further Scale for TCM syndrome differentiation.
2 Establish differentiation criteria based on TCM syndrome elements
2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among experts
2.1.1 Common syndrome factors of ulcerative colitis
96 questionnaires were gived out and took back. The callback rate was 100%. In accordance with cumulative percentage of common, more common and very common more than 75% and the coefficient variation less than 0.40, the common TCM syndrome factors of ulcerative colitis were confirmed.The syndrome factors related to disease location were large intestine,spleen, intestine collaterals,stomach, kidney, liver, and those related to the nature of disease were damp, qi deficiency, qi stagnation, yang deficiency, blood stasis, excessive heat, blood deficiency and yin deficiency.
2.1.2 Symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis
On the basis of previous research analysis,there were 152 symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis.53 symptoms and signs were in the diagnosis of corresponding disease location TCM syndrome elements of ulcerative colitis,9 items corresponding liver,6 items corresponding heart,14 items corresponding spleen,5 items corresponding lung,9 items corresponding kidney,8 items corresponding stomach,12 items corresponding large intestine,2 items corresponding bowel collaterals.99 symptoms and signs were in the diagnosis of corresponding disease nature TCM syndrome elements of ulcerative colitis,13 items corresponding qi deficiency,8 items corresponding xue deficiency,17 items corresponding yin deficiency,18 items corresponding yang deficiency,17 items corresponding dampness,18 items corresponding fire,6 items corresponding cold, 11 items corresponding qi stagnation,11 items corresponding qi sinking,10 items corresponding blood stasis,11 items corresponding fluid retention.
2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigation
The threshold of every TCM syndrome element was 10 in the questionnaire. The range of the weighting coefficient of every symptom was 1 to 10 point.The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)
The symptoms and signs corresponding to 8 TCM syndrome elements related to disease location and the range of weighting coefficient were listed as follows.①liver:" Emotional depression" etc 9 symptoms and signs (7.49～4.18).②heart:"Palpitation" etc 6 symptoms and signs (6.90～5.51).③spleen:"Loose stool" etc 14 symptoms and signs (7.96～ 5.55).④lung:"Susceptibility to colds" etc 5 symptoms and signs (6.30～5.27).⑤kidney:"Diarrhea before dawn" etc 9 symptoms and signs(7.82～5.71).⑥stomach:"Distension and fullness in the stomach" etc 8 symptoms and signs (7.53～6.15).⑦large intestine:"Stools containing pus and blood" etc 12 symptoms and signs (8.40～6.70).⑧bowel collaterals:"Stools containing pus and blood" etc 2 symptoms and signs (8.49～6.41)
The symptoms and signs corresponding to 11 TCM syndrome elements related to disease nature and the range of weighting coefficient were listed as follows.①qi deficiency:"Qi deficiency and disinclination to talk" etc 13 symptoms and signs (7.44～5.60).②xue deficiency:"Pale lips, nails and eyelids" etc 8 symptoms and signs (7.90～5.59).③yin deficiency:"Dysphoria with feverish sensation in chest, palms and soles" etc 17 symptoms and signs (6.88～4.91).④yang deficiency:"Cold limbs" etc 18 symptoms and signs (7.54｀5.57).⑤dampness:"Mucous stools" etc 17 symptoms and signs(7.91～4.96).⑥excess heat(fire):"Burning sensation in the anus" etc 18 symptoms and signs (7.13～5.69).⑦excess cold:"Cold abdominal pain, worse by pressure" etc 6 symptoms and signs (7.51～6.14).⑧qi stagnation:"Distending pain in the abdomen" etc 11 symptoms and signs (7.38～5.88).⑨qi sinking:"Tenesmus feeling of anus" etc 2 symptoms and signs (7.65～7.43).10 blood stasis: "Ecchymosis on tongue" etc10 symptoms and signs (7.60～5.79).(11)fluid retention "Borborygmus" etc 11 symptoms and signs (7.08～4.46)
2.3 Establish standardization of the syndrome differentiation of ulcerative colitis based TCM syndrome elements
This standardization is with the diagnosis of syndrome elements as the core. When diagnosis of syndrome elements was determined, syndrome elements were combined flexibly based on traditional Chinese medicine syndrome differentiation and common syndrome types of disease.
The threshold of every TCM syndrome element was 10. The range of the weighting coefficient of every symptom was 1 to 10 point.1 point standed for the least weighting coefficient while 10 point standed for the most weighting coefficient. When one symptom was 10 point,the diagnosis was made.Or two more symptoms were above 10 point, the diagnosis of the TCM syndrome element was made.
The diagnosis contribution of symptoms corresponding to syndrome elements is valued by the mode and mean. According to the principle of equal difference and point deduction, the scores of symptoms were translate into the index of criteria.
2.3.1 Differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease location
(1) Large intestine:Stools containing pus and blood(10 points); Mucous stool(10 points); Difficult defecation and sticky stools(10 points); Loose stool(8 points); Burning pain in the anus(8 points); Stool sometimes sloppy and sometimes bound(8 points); Diarrhea(8 points); Borborygmus(7 points); Constipation(6 points); Abdominal pain(6 points); Abdomen distention(6 points); Increased flatus(6 points).
(2) Spleen:Teeth-printed tongue(9 points); Plump tongue(9 points); Loose stool(9 points); Diarrhea(9 points); Stool sometimes sloppy and sometimes bound(8 points); Anorexia(7 points); Sallow complexion(7 points); Abdomen distention(6 points); Soft pulse(5 points); Abdominal pain(5 points); Mucous stools(5 points); Moderate pulse(5 points); Stools containing pus and blood(4 points); Thready pulse(4 points).
(3) Stomach:Distension and fullness in the stomach(10 points); Stuffiness and fullness in the stomach(9 points); Epigastric pain(9 points); Belching(6 points); Nausea(5 points); Vomiting(5 points); Acid regurgitation(5 points); Anorexia(5 points).
(4) Kidney:Diarrhea before dawn(10 points); Soreness and weakness of waist and knees(9 points); Frequent urination at night(9 points); Aching pain in waist and knees(8 points); Weak pulse at the chi portion(6 points); Fear cold of lower limbs(6 points); Deep pulse(5 points); Diarrhea with undigested food(5 points); Tinnitus(4 points).
(5) Liver:Stringy pulse(9 points); Distension and fullness in chest and hypochondrium(8 points); Irritability(8 points); Emotional depression(7 points); Hypochondriac pain(7 points);Deep sighing(5 points); Distension and fullness in the lateral lower abdomen(6 points); Bitter taste in the mouth(5 points);Oppression in the chest(1 points).
(6) Lung:Susceptibility to colds(5 points); Spontaneous sweating(5 points); Aversion to wind(5 points); Shortness of breath(5 points); Oppression in the chest(1 points).
(7) Heart:Palpitation(8 points); Insomnia(5 points); Vexation(5 points); Oppression in the chest(4 points); Dreaminess(4 points); Shortness of breath(4 points).
If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made.
2.3.2 differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease nature
(1) Dampness:Greasy coating(10 points); Sticky slimy sensation in the mouth(10 points); Difficult defecation and mucous stools(8 points); Mucous stools(8 points); Stools with the blood and pus; more pus and less blood(7 points); Tenesmus(6 points); Stools containing pus and blood; blood as much as pus(6 points); Slippery pulse(6 points); Borborygmus(5 points); Teeth-printed tongue(5 points); Plump tongue(5 points); Soft pulse(4 points); Moderate pulse(4 points); Thirst without a desire to drink(4 points); Stuffiness and fullness in the stomach(4 points); Analeptic(3 points); Thready pulse(2 points).
(2) Qi deficiency:Qi deficiency and disinclination to talk(8 points); Spiritlessness(8 points); Spontaneous sweating(8 points); Teeth-printed tongue(8 points); Weakness(7 points); Weak pulse(6 points); Feeble pulse(6 points); Pale tongue(6 points); Pale white complexion(6 points); Sallow complexion(6 points);Thready pulse(5 points); Dizziness(4 points); Dull pain in the abdomen(4 points).
(3) Qi stagnation:Distending pain of hypochondrium(8 points); Stringy pulse(7 points); Distension and fullness in hypochondrium(7 points); Distending pain in the abdomen(7 points);Abdominal distention(7 points); Distending pain in the stomach(6 points); Distension and fullness in stomach(6 points);Tenesmus(6 points); Emotional depression(6 points); Irritability(5 points); Oppression in the chest(4 points).
(4) Yang deficiency:Diarrhea before dawn(9 points); Cold limbs(9 points); Fear of cold(9 points); Frequent urination at night(8 points); Abdominal pain; alleviated by heat and pressure(7 points); Clear urine in large amounts(7 points); Bright pale complexion(7 points); Feeble pulse(7 points); Diarrhea with undigested food(6 points); Slow pulse(6 points); Plump tongue(6 points); Teeth-printed tongue(6 points); Pale tongue(5 points); Slippery fur(5 points); Spontaneous sweating(4 points); Bland taste in the mouth with no desire for drinking(4 points); Moist fur(4 points); Pale purple tongue(4 points).
(5) Blood stasis:Ecchymosis on tongue(10 points); Abnormal sublingual vessel(9 points); Hesitant pulse(8 points); Squamous and dry skin(8 points); Deep purple tongue(8 points); Mass in the abdomen(7 points); Cyanotic lips(7 points); Impalpable abdominal pain with fixed location(6 points); Dim complexion(5 points); Black stools(4 points).
(6) Excessive heat (fire):Burning sensation in the anus(8 points); Yellow fur(8 points); Rapid pulse(8 points); Red complexion(7 points); Halitosis(7 points); Dry fur(7 points); Stools containing pus and blood; more blood and less pus(6 points); Bitter taste in the mouth(6 points); Dark urine(5 points); Red tongue(5 points); Deep red tongue(5 points); Thirst(5 points); Dry stools(5 points); Stools containing pus and blood; blood as much as pus(5 points); Slippery pulse(5 points); Fever(4 points); Dry mouth(4 points); Tenesmus(4 points).
(7) Xue deficiency:Pale lips;nails and eyelids(10 points); Pale tongue(9 points); Sallow complexion(8 points); Pale white complexion(8 points); Thready pulse(6 points); Dizziness(5 points); Scanty menstruation(5 points); Amenorrhea (4 points).
(8) Yin deficiency:Dysphoria with feverish in the chest; palms and soles(8 points); No fur(8 points); Little fur(6 points); Eroded fur(6 points); Thready and rapid pulse(6 points); Night sweating(6 points); Mild fever in the night(5 points); Mild fever in the afternoon(6 points); Fissured tongue(5 points); Thin tongue(5 points); Dry mouth and throat(5 points); Hectic cheek(4 points); Deep red tongue(4 points); Red tongue(4 points); Constipation(3 points); Dull pain in the abdomen(2 points); Dizziness(2 points).
(9) Qi sinking:Tenesmus feeling of anus(10 points); Tenesmus feeling of abdomen(8 points).
(10) Excessive cold:Cold abdominal pain; worse by pressure(10 points); Tight pulse(7 points); Cold limbs(5 points); Slow pulse(5 points); Stools containing pus and blood; more pus and less blood(5 points); White fur(5 points).
(11) Fluid retention:Borborygmus(7 points); Slippery fur(6 points); Slippery pulse(5 points); Plump tongue(5 points); Diarrhea(5 points); Greasy fur(5 points); Stuffiness and fullness in the stomach(3 points); Distention in the abdomen(3 points); Deep pulse(3 points); Stringy pulse(2 points); Tight pulse(1 points).
If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made.
3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitis
The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.It was divided into severn parts,the first part was about general information of patients,the second part was about victim's past medical history,the third part was diagnostic criteria of ulcerative colitis,the fourth part was inclusive criteria and exclusion criteria,the fifth part was symptoms and signs,the sixth part was diagnosis of syndrome elements,the seventh part was result of syndrome differentiation.
The experts were titled as chief physician, and had practiced medicine regarding digestive system diseases for a long time. By comparing and analysing traditional Chinese medicine dialectical results of the experience of expert and scale, ten syndrome elements were consistent (66.7%).They were respectiely liver, spleen, stomach,large intestine, qi deficiency, blood deficiency, dampness, excess heat, excess cold, qi sinking. Five syndrome elements were not consistent (33.3%).They were lung, kidney, yang deficiency, qi stagnation,and blood stasis.
All the 37 syndrome types by expert experience could be formulated by the syndrome elements of syndrome differentiation standard.The information collection and syndrome differentiation efficacy of scale were tested.The scale played an important role in syndrome differentiation. But there were needs for modifications and improvements.
Conclusion
1 On the basis of binding of illness and syndrom, TCM syndrome elements, the scale with the functions of collectting disease information, TCM information of four methods and syndrome differentiation was established. It could not only collect four physical examinations information fully and objectively, and also provide a practical tool for syndrome differentiation. It reflected wholeness and flexibility of syndrome differentiation. It could provide template for further Scale for TCM syndrome differentiation.
2 Based on the previous study,the expert questionnaire was established.Through questionnaire to the experts and the analysis of questionnaire, the syndrome elements and their characteristics were further confirmed. Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core..It simplifies the complexity and the multidimensional nature of syndrome differentiation.
3 The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease and four diagnostic information and syndrome differentiation.By comparing and analysing traditional Chinese medicine dialectical results of 62 cases by the experience of expert and scale,the practical applicability and operability of the scale were showed.
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